Oral Misoprostol for Cervical Priming Before Hysteroscopy

Use of Oral Misoprostol for Cervical Priming Before Hysteroscopy: a Randomized Comparison of Two Dosages

A randomized, double blind study to compare 200 and 400 mcg misoprostol for cervical preparation before hysteroscopy.

Study Overview

• Status: Completed
• Conditions: Adverse Effects; Cervical Laceration
• Intervention / Treatment: Drug: Misoprostol administered orally one hour before surgery

Detailed Description

All patients admitted for hysteroscopy were offered participation in the study, and those choosing to participate were assessed according to the inclusion and exclusion criteria of the study protocol. The investigators included all non pregnant patients who were considered medically fit and scheduled for operative hysteroscopy, regardless of age or indication of the hysteroscopy. Patients with a positive history of vascular or coronary artery disease and patients using other products that could affect the consistency of the cervix such as local estrogen or laminaire were excluded from the study. To achieve a mean difference of 0.5 in the diffculty of dilation and a mean difference of 0.5 in the First Hegar with a power of 80% at 0.05 statistical significance, a sample of 163 patients in each arm is needed. However, the investigators patients pool did not permit to recruit more than 70 women so the investigators took it as a convenience sample of a total of 70 women that agreed to be recruited for the trial. An informed consent was obtained after explaining to the patients the benefit and the eventual risk or adverse effects associated with the medication. Studied factors were: age, parity, reason for the procedure, history of cervical dilation and history of cervical surgery.

Seventy closed and numbered envelopes, containing a capsule with either 200mcg or 400mcg of misoprostol were randomly distributed to these 70 patients. Each envelope was coded randomly and only the pharmaceutical department of the hospital knew the content of these envelopes and kept a list of their codes.

The misoprostol was administered by the floor nurse, per-os to the patient one hour before hysteroscopy with a small amount of water. The number on the envelope was noted by the nurse on the document relative to the patient. Hence, the patient, the physician performing the biopsy, the nurse and the research associate did not know the exact dose of misoprostol that was ingested by the patient.

Three physicians contributed to the study. Before beginning the procedure, the operator noted by pelvic examination the position of the cervix. He then noted the size/number of the first Hegar dilator used, the maximal dilation reached, the difficulty to dilate during the intervention (measured by a scale from 1 to 10), cervical injuries, bleeding or uterine perforation and the duration of the operation. A rigid hysteroscope (Storz, 27 F) was used for all procedures.

Adverse effects that could be related to misoprostol (uterine cramps, nausea, vomiting, diarrhea and fever), were reported before and up to 6 hours after surgery.

Statistical analysis was performed using SPSS version 18. Means comparison was done using t-test for continuous variables such as difficulty in dilation or first Hegar (the data was normally distributed). Frequency and percent distribution were compared between the two treatment groups using χ2 test when the expected cell count was 5 or more; in cases where the expected cell count was less than 5, the Fisher exact test was used instead

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 11234
    • Hôtel-Dieu De France University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All patients admitted for hysteroscopy were offered participation in the study, and those choosing to participate were assessed according to the inclusion and exclusion criteria of the study protocol

Description

Inclusion Criteria:

• non pregnant patients
• considered medically fit without any life threatening conditions
• scheduled for operative hysteroscopy, regardless of age or indication of the hysteroscopy

Exclusion Criteria:

• a positive history of vascular or coronary artery disease
• using other products that could affect the consistency of the cervix such as local estrogen or laminaire

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
200 mcg misoprostol; Misoprostol administered orally one hour before surgery	Drug: Misoprostol administered orally one hour before surgery; Closed and numbered envelopes, containing a capsule with either 200mcg or 400mcg of misoprostol were randomly distributed to the patients. Each envelope was coded randomly and only the pharmaceutical department of the hospital knew the content of these envelopes and kept a list of their codes. The misoprostol was administered by the floor nurse, per-os to the patient one hour before hysteroscopy with a small amount of water. The number on the envelope was noted by the nurse on the document relative to the patient. Hence, the patient, the physician performing the biopsy, the nurse and the research associate did not know the exact dose of misoprostol that was ingested by the patient.; Other Names: ( Cytotec*)
400 mcg misoprostol; Misoprostol administered orally one hour before surgery	Drug: Misoprostol administered orally one hour before surgery; Closed and numbered envelopes, containing a capsule with either 200mcg or 400mcg of misoprostol were randomly distributed to the patients. Each envelope was coded randomly and only the pharmaceutical department of the hospital knew the content of these envelopes and kept a list of their codes. The misoprostol was administered by the floor nurse, per-os to the patient one hour before hysteroscopy with a small amount of water. The number on the envelope was noted by the nurse on the document relative to the patient. Hence, the patient, the physician performing the biopsy, the nurse and the research associate did not know the exact dose of misoprostol that was ingested by the patient.; Other Names: ( Cytotec*)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of cervical dilatation	Measured by a scale from 1 to 10	Assessed during the surgery and recorded immediately at the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	uterine cramps, nausea, vomiting, diarrhea and fever	recorded till 6 h following surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications during hysteroscopy	cervical injuries, bleeding or uterine perforation	recorded immediately at the end of surgery

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Assaad K Kesrouani, MD, Saint-Joseph University

Publications and helpful links

General Publications

• Lee YY, Kim TJ, Kang H, Choi CH, Lee JW, Kim BG, Bae DS. The use of misoprostol before hysteroscopic surgery in non-pregnant premenopausal women: a randomized comparison of sublingual, oral and vaginal administrations. Hum Reprod. 2010 Aug;25(8):1942-8. doi: 10.1093/humrep/deq083. Epub 2010 Jun 11.
• Bastu E, Celik C, Nehir A, Dogan M, Yuksel B, Ergun B. Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. Int Surg. 2013 Apr-Jun;98(2):140-4. doi: 10.9738/INTSURG-D-12-00024.1.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 7, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2014
• Last Update Submitted That Met QC Criteria: June 7, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Cervical; Oral; Misoprostol; Hysteroscopy
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: USJ-002